Position Summary
The Regulatory Clinical Research Coordinator position is to support our growing Orthopaedic research program including clinical research coordinators (CRCs) and principal investigators (PIs) with clinical research start-up and regulatory activities. This role is responsible for maintaining regulatory compliance across multiple protocols while supporting research professionals and faculty to ensure studies are conducted efficiently accurately and in accordance with institutional policies federal regulations and Good Clinical Practice ( GCP ). The key responsibilities include preparing submitting and maintaining regulatory documents for IRB submissions including initial submissions amendments continuing reviews and reportable events maintaining complete and audit-ready regulatory binders (electronic and/or paper) assisting with investigator documentation (e.g. CVs licenses CITI / GCP training records delegation of authority logs) and supporting study start-up activities including regulatory approvals and site readiness and feasibility.
Required Qualifications Competencies And Experience
Comfortable engaging patients via phone conversations.
Preferred Qualifications Competencies And Experience
Recruitment experience.
Work Schedule
To be determined by supervisor and selected candidate.
Required Experience:
Staff IC
Position SummaryThe Regulatory Clinical Research Coordinator position is to support our growing Orthopaedic research program including clinical research coordinators (CRCs) and principal investigators (PIs) with clinical research start-up and regulatory activities. This role is responsible for maint...
Position Summary
The Regulatory Clinical Research Coordinator position is to support our growing Orthopaedic research program including clinical research coordinators (CRCs) and principal investigators (PIs) with clinical research start-up and regulatory activities. This role is responsible for maintaining regulatory compliance across multiple protocols while supporting research professionals and faculty to ensure studies are conducted efficiently accurately and in accordance with institutional policies federal regulations and Good Clinical Practice ( GCP ). The key responsibilities include preparing submitting and maintaining regulatory documents for IRB submissions including initial submissions amendments continuing reviews and reportable events maintaining complete and audit-ready regulatory binders (electronic and/or paper) assisting with investigator documentation (e.g. CVs licenses CITI / GCP training records delegation of authority logs) and supporting study start-up activities including regulatory approvals and site readiness and feasibility.
Required Qualifications Competencies And Experience
Comfortable engaging patients via phone conversations.
Preferred Qualifications Competencies And Experience
Recruitment experience.
Work Schedule
To be determined by supervisor and selected candidate.
Required Experience:
Staff IC
View more
View less